NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) announced early clinical observations in a three-year-old boy with an aggressive brain tumor who is receiving investigational intranasal NEO100 through the company's Compassionate Care program in Abu Dhabi, United Arab Emirates.

According to the child's treating physicians, the patient is now breathing independently without ventilator support and is beginning to move his legs following initiation of treatment. The company cautioned that these observations involve a single patient receiving compassionate-use treatment and do not establish that NEO100 caused the improvement or predict outcomes in other patients.

The patient did not meet eligibility criteria for NeOnc's NEO100-03 pediatric clinical trial and is receiving treatment outside that trial. The Compassionate Care program provides access to NEO100 for patients with serious or life-threatening conditions who have no comparable or satisfactory treatment alternatives.

"This individual experience does not establish safety or efficacy," said Thomas Chen, MD, PhD, Chief Medical Officer and Chief Scientific Officer of NeOnc. "Our pediatric clinical program is designed to evaluate NEO100 systematically in children with serious brain tumors."

NEO100 is a highly purified form of perillyl alcohol administered intranasally. Its safety and efficacy in pediatric patients have not been established.

The treatment was coordinated between NeOnc, the child's treating physicians, and the Department of Health – Abu Dhabi. In June 2026, the Department of Health – Abu Dhabi granted IND authorization for NEO100 across the NEO100-01, NEO100-02, and NEO100-03 protocols. In March 2025, the U.S. Food and Drug Administration granted Rare Pediatric Disease Designation to NEO100 for pediatric-type diffuse high-grade gliomas. Neither authorization constitutes approval for commercial use.